SGM-101 in Colorectal Brain Metastases. (SGM-CBM)

Leiden University Medical Center (LUMC)

Status and phase: Enrolling; Phase 2

Conditions: Brain Metastases; Brain Tumor; Rectum Cancer; Gastrointestinal Cancer; Gastrointestinal Neoplasms; Brain Cancer; Intestinal Disease; Gastrointestinal Disease; Intestinal Neoplasms; Colorectal Neoplasms; Rectal Neoplasms; Brain Diseases; Brain Neoplasms

Treatments: Drug: SGM-101

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04755920

NL74956.058.20

Details and patient eligibility

About

This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent prior to any study-mandated procedure;
2. Patients aged over 18 years old;
3. All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
5. Diagnosed with brain metastasis of colorectal origin and scheduled for a resection.

Exclusion criteria

1. History of any anaphylactic reaction;

2. Previous use of SGM-101;

3. Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;

4. Laboratory abnormalities defined as:

   1. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
   2. Total bilirubin above 2 times the ULN or;
   3. Serum creatinine above 1.5 times the ULN or;
   4. Platelet count below 100 x 109/L or;
   5. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
   6. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;

5. Patients pregnant or breastfeeding;

6. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Patients with colorectal brain metastases

Experimental group

Description:

10 mg SGM-101, administration 3 to 5 days prior to surgery.

Treatment:

Drug: SGM-101